A Study of RO5428029 in Healthy Volunteers and Patients W... | NCT01371162

Studies
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

NCT01371162

Sponsor

Hoffmann-La Roche

Status

Completed

Last Update Posted

Nov 2, 2016Estimated

Enrollment

42Actual

Phase

Phase 1

Conditions

Hepatitis C, Chronic, Healthy Volunteer

Interventions

RO5428029
placebo

Countries

France
Netherlands
Poland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2011

Primary Completion Date

Dec 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 6, 2011

First Submission Date that Met QC Criteria

Jun 9, 2011

First Posted Date

Jun 10, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2016

Last Update Posted Date

Nov 2, 2016Estimated

Description Module

Brief Summary

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

42Actual

Label	Type	Intervention Names
A1 Healthy Volunteers	Experimental	Drug: RO5428029
A2	Placebo Comparator	Drug: placebo
B1 HCV Infection	Experimental	Drug: RO5428029
B2	Placebo Comparator	Drug: placebo

Name	Type	Description	Arm Group Labels	Other Names
RO5428029	Drug	Multiple ascending doses	A1 Healthy Volunteers B1 HCV Infection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Part B: Viral load response: HCV RNA (assessed by Roche COBAS Taqman HCV Test)		up to 17 days
Parts A + B: Safety: Incidence of adverse events		up to 24 days
Parts A + B: Pharmacokinetics: Area under the concentration - time curve (AUC)		up to 24 days

Secondary Outcomes

Measure	Description	Time Frame
Part B: Viral resistance (viral breakthrough/non-response/partial response) HCV RNA assessed by Roche COBAS Paqman HCV Test		up to 17 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive
Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg
Female subjects/patients must be surgically sterile or post-menopausal
Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception
For HCV patients:
Hepatitis C genotype 1 of > 6 months duration at screening
HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening
HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)
Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis

Exclusion Criteria:

Pregnant or lactating women, and male partners of women who are pregnant or lactating
Positive test for drugs of abuse
History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol
History or symptoms of any significant disease or disorder
History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)
Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)
For HCV patients:
Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening
Evidence of cirrhosis and/or incomplete transition to cirrhosis
Presence or history of non-hepatitis C liver disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
		Montpellier		34094	France

ID	Term
D006526	Hepatitis C
D000092122	Bronchiolitis Obliterans Syndrome

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D006525	Hepatitis, Viral, Human